FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
18217–18240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2021
ACS LD Uni FB Knee System
K203341 · HSX
Implantcast GmbH
Orthopedic · 57d
Cleared Jan 08, 2021
BioGuard Air/Water and Suction Valves
K203630 · ODC
Steris Corporations
Gastroenterology & Urology · 28d
Cleared Jan 07, 2021
SurgiWrap FROST
K200918 · FTL
Mast Biosurgery
General & Plastic Surgery · 276d
Cleared Jan 07, 2021
MatriDerm
K201577 · KGN
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 210d
Cleared Jan 07, 2021
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision...
K202405 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 139d
Cleared Jan 07, 2021
BrainInsight
K202414 · LLZ
Hyperfine Research, Inc.
Radiology · 136d
Cleared Jan 07, 2021
ZSFab Cervical Interbody System
K202488 · ODP
Zsfab, Inc.
Orthopedic · 129d
Cleared Jan 07, 2021
Instylla Delivery Kit
K202544 · FMF
Instylla, Inc.
General Hospital · 127d
Cleared Jan 07, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested...
K202622 · LZA
O&M Halyard, Inc.
General Hospital · 119d
Cleared Jan 07, 2021
TissueTak device
K203117 · GDW
Via Surgical , Ltd.
General & Plastic Surgery · 83d
Cleared Jan 07, 2021
MULTIX Impact
K203345 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jan 06, 2021
Applied Medical Anoscope
K200021 · FER
Applied Medical Resources
Gastroenterology & Urology · 366d
Cleared Jan 06, 2021
BTL-703-2
K200382 · NGX
Btl
Physical Medicine · 323d
Cleared Jan 06, 2021
InBody
K200560 · DXN
Inbody Co., Ltd.
Cardiovascular · 308d
Cleared Jan 06, 2021
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
K200769 · ODC
Wilson Instruments (Sha) Co., Ltd.
Gastroenterology & Urology · 287d
Cleared Jan 06, 2021
Thermidas IR System (ThIR-A615)
K200999 · LHQ
Thermidas Americas, Inc.
Radiology · 265d
Cleared Jan 06, 2021
SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
K202350 · IZL
Shantou Institute of Ultrasonic...
Radiology · 141d
Cleared Jan 06, 2021
Disposable Surgical Face Mask
K202491 · FXX
Jiangsu Newvalue Medical Products...
General Hospital · 128d
Cleared Jan 06, 2021
SIRION Lateral Lumbar Interbody Fusion
K202495 · MAX
Astura Medical, LLC
Orthopedic · 128d
Cleared Jan 06, 2021
Medical Surgical Masks-Non Sterile
K202594 · FXX
Shandong T&F Nonwoven Co., Ltd.
General Hospital · 120d
Cleared Jan 06, 2021
AutoStrut G2
K202810 · KTT
Orthospin, Ltd.
Orthopedic · 105d
Cleared Jan 06, 2021
Medical Surgical Gowns
K202844 · FYA
Beijing Biosis Healing Biolog Ical...
General Hospital · 103d
Cleared Jan 06, 2021
NEOLab Clear Aligners
K203339 · NXC
New England Ortho Lab, Inc.
Dental · 55d
Cleared Jan 06, 2021
MULTIX Impact C
K203340 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 55d